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Potassium Chloride 15%W/V Concentrate For Solution For Infusion

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Document: leaflet MAH GENERIC_PL 02848-5917R change

MercuryPharma

PATIENT INFORMATION LEAFLET

Potassium Chloride 15% w/v Concentrate for Solution for Infusion

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Potassium Chloride 15% w/v Concentrate for Solution for Infusion but will be referred to as ‘Potassium chloride concentrate’ throughout the remainder of this leaflet.

In this leaflet:

1.    What Potassium chloride concentrate is and what it is used for

2.    Before you are given Potassium chloride concentrate

3.    How you are given Potassium chloride concentrate

4.    Possible side effects

5.    How to store Potassium chloride concentrate

6.    Further information

1. WHAT POTASSIUM CHLORIDE CONCENTRATE AND WHAT IT IS USED FOR

Potassium chloride concentrate belongs to a group of medicines called electrolyte replacement solutions. Electrolytes are a group of chemicals and salts that are in the body fluids.

Potassium chloride concentrate is used in patients needing additional amounts of potassium.

Make sure your doctor knows if you suffer from the above.

Take special care with Potassium chloride concentrate if you:

•    have heart disease

•    have had a recent severe injury involving a large area of skin such as a burn.

Make sure your doctor is aware of these situations if it is not already obvious.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

•    Diuretics (“water tablets”) like amiloride, spironolactone and triamterene

•    Other medicines containing potassium

•    ACE inhibitors, and angiotensin II antagonists, aliskerin (used to treat high blood pressure)

•    Ciclosporin, Tacrolimus (used to supress the immune system following transplants)

•    Glucose infusions (used in patients who have low levels of sugar in their blood or are dehydrated).

Pregnancy and breast feeding

Do not have Potassium chloride concentrate if you are pregnant (or think you may be), or breast feeding unless your doctor has decided that it is in your best interests.

2. BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE

You should not be given Potassium chloride

concentrate if :

•    you have hyperkalaemia (high levels of potassium in your blood - your doctor will advise you)

•    you suffer from impaired kidney function (you may produce little or no urine)

•    you suffer from Addison’s disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin)

•    you are very dehydrated

•    you suffer from heat cramps

•    you suffer from Hyperchloraemia (electrolyte disturbance in which there is an abnormally elevated level of the chloride ion in the blood).

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Potassium chloride concentrate should not interfere with your ability to drive or use machines but consult your doctor first.

3. HOW YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE

Potassium chloride concentrate is diluted and then slowly dripped through a needle into a vein. The process may take an hour or more depending on your dose. Your doctor will decide the best dose for you.

While this medicine is being injected, your ECG (electrocardiogram, measuring the heart) should be monitored continuously.

If you are given more Potassium chloride concentrate than you should

As Potassium chloride concentrate is administered by a healthcare professional it is unlikely that you will be given too much. If you think you have been given too much medicine, tell your doctor. The likely signs of an overdose are the occurrence of side-effects as listed below.

In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you miss a dose of Potassium chloride concentrate

This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose speak to your doctor.

•    Muscle weakness or loss of movements

•    Faintness or irregular heart beats, or heart attack

•    Hyperkalaemia (too much potassium in the blood which would be identified by a blood test)

•    Hypotension (low blood pressure causing dizziness on standing)

•    Pain at the site of injection

•    Inflammation of the vein into which the solution is injected.

Please tell your doctor as soon as possible if you experience any of the above or are concerned they may have occurred.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor (GP or hospital doctor) or pharmacist.

5. HOW TO STORE POTASSIUM CHLORIDE CONCENTRATE

These instructions apply mainly to the healthcare professional administering the injection.

Keep this medicine out of the sight and reach of children

This medicine should be stored out of the light at a maximum temperature of 25°C. Do not use after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.

Do not use if the ampoule is damaged or if the solution is cloudy or has solids in it. If only part of the ampoule is used, throw away the rest of the solution

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines Potassium chloride concentrate can sometimes cause side-effects, although not everybody gets them.

The most likely side-effects are:

• Tingling or other odd sensations


The active substance is potassium chloride.

The other ingredient is water for injections.

Potassium chloride concentrate must be diluted before use to not less than fifty times its volume of sodium chloride injection or other suitable liquids for dilution.

What Potassium chloride concentrate looks like and contents of pack

Potassium chloride concentrate is a clear, colourless, sterile aqueous solution for injection. Each 10ml glass ampoule contains 15%w/v (1.5g) of active ingredient, potassium chloride. Potassium chloride concentrate is supplied in pack of 10 ampoules.

Marketing Authorisation Holder

Mercury Pharma International Ltd

4045, Kingswood Road, City West Business Park, Co

Dublin, Ireland.

Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

This leaflet was last revised in September 2012.